Designing robust preparative purification processes with high performance

Chemical Engineering and Technology

Volumn 31, Issue 6, 2008, Pages 875-882

  Degerman, Marcus ^a   Jakobsson, Niklas ^a   Nilsson, Bernt ^a  

^a LUND UNIVERSITY   (Sweden)

Author keywords

Modeling; Optimization; Purification; Robustness

Indexed keywords

CHEMOTHERAPY; CHROMATOGRAPHIC ANALYSIS; DRUG DELIVERY; DRUG DOSAGE; DRUG PRODUCTS PLANTS; ION CHROMATOGRAPHY; ION EXCHANGE; OPTIMIZATION; PROCESS ENGINEERING;

CHROMATOGRAPHIC PROCESSES; DESIGN PROCESSES; DESIGNING ROBUST; DOWNSTREAM PROCESSING; IMMUNOGLOBULIN G; ION EXCHANGE CHROMATOGRAPHY; MODEL-BASED METHODS; MODELING; OPERATING CONDITIONS; PHARMACEUTICAL DRUGS; PHARMACEUTICAL INDUSTRIES; PREPARATIVE PURIFICATION; PROCESS PERFORMANCE; PRODUCTION COSTS.; PURIFICATION PROCESSES; ROBUSTNESS;

PURIFICATION;

EID: 46049094400     PISSN: 09307516     EISSN: 15214125     Source Type: Journal    
DOI: 10.1002/ceat.200800097     Document Type: Article

References (29)

1. B. Chatterjee, J. Green, Pharm. Eng. 2007, 27, 2.
2. Guidance for Industry PAT - A Framework for Innovative Pharmaceutical Manufacturing and Quality Assurance, US Food and Drugs Administration, US Department of Health and Human Services, Rockvi]le, U. S. 2004.
3. ICH, ICH harmonised tripartite guideline: Pharmaceutical development Q8, 2005.
4. ICH, ICH harmonised tripartite guideline: Quality Risk Management Q9, 2005.
5. K. M. Thompson, D. E. Burmaster, E. A. C. Crouch, Risk Anal. 1992, 12, 53.
6. F. O. Hoffman, J. S. Hammonds, Risk Anal. 1994, 14, 707.
7. H. M. Wagner, Operations Res. 1995, 43, 948.
8. A. Saltelli, S. Tarantola, F. Campolongo, Stat. Sci. 2000, 15, 377.
9. J. C. Helton, J. D. Johnson, C. J. Sallaberry, C. B. Storlie, Rel. Eng. Syst. Saf. 2006, 91, 1175.
10. J. C. Helton, F. J. Davis, Risk Anal. 2002, 22 (3), 591.
11. J. M. P. King, N. J. Titchener-Hooker, Y. Zhou, Bioprocess Biosyst. Eng. 2007, 30, 123.
12. J. C. Helton, F. J. Davis, Rel. Eng. Syst. Saf. 2003, 81, 23.
13. N. Jakobsson et al., J. Chromatogr., A 2005, 1063, 99.
14. D. Karlsson, N. Jakobsson, A. Axelsson, B. Nilsson, J. Chromatogr., A 2004, 1055, 29.
15. D. Karlsson et al., J. Chromatogr., A 2004, 1033, 71.
16. P. Persson, H. Kempe, G. Zacchi, B. Nilsson, Chem. Eng. Res. Des. 2004, 82, 1.
17. C. Mattisson, D. Karlsson, S. Pettersson, G. Zacchi, A. Axelsson, J. Phys. D: Appl. Phys. 2001, 34, 3088.
18. D. Karlsson, G. Zacchi, A. Axelsson, Biotechnol. Prog. 2002, 18, 1423.
19. H. Schmidt-Traub, Preparative Chromatography of Fine Chemicals and Pharmaceutical Agents, Wiley-VCH, Weinheim 2005.
20. G. Guiochon, A. Felinger, D. G. Shirazi, A. M. Katti, Fundamentals of Preparative and Nonlinear Chromatography, Elsevier, San Diego, CA 2006.
21. N. Jakobsson, M. Degerman, E. Stenborg, B. Nilsson, J. Chromatogr., A 2007, 1138, 109.
22. W. R. Melander, S. El Rassi, C. Horváth, J. Chromatogr., A 1989, 469, 3.
23. N. Jakobsson, M. Degerman, B. Nilsson, J. Chromatogr., A 2005, 1099, 157. 24 S. R. Gallant, S. Vunnum, S. M. Cramer, J. Chromatogr., A 1996, 725, 295.
24. S. R. Gallant, A. Kundu, S. M. Cramer, J. Chromatogr., A 1995, 702, 125.
25. T. Ishihara, T. Kadoya, S. Yamamoto, J. Chromatogr., A 2007, 1162, 34.
26. T. Ishihara, S. Yamamoto, J. Chromatogr., A 2005, 1069, 99.
27. M. Degerman, N. Jakobsson, B. Nilsson, J. Chromatogr., A 2007, 1162, 41.
28. B. Dejaegher, Y. V. Heyden, J. Chromatogr., A 2007, 1158, 138.
29. M. Degerman, N. Jakobsson, B. Nilsson J. Chromatogr., A 2006, 1113, 92.